NCT02890836

Brief Summary

Aim: First, to investigate the prevalence of a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure in pregnant women with pre-existing diabetes. Second, to explore the prevalence of preeclampsia and preterm delivery in women with pre-existing diabetes with a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure before entering the third trimester of pregnancy. Third, to explore the influence of lifestyle, gestational weight gain and mental well-being on confirmed hypertension and preeclampsia in pregnant women with diabetes.The recruitment period was in 2018 extended to 2020 to perform the following studies: First whether home BP in early pregnancy is superior to office BP to predict preeclampsia. Second to evaluate the prevalence of preeclampsia after initiation of a new treatment strategy including prophylactic aspirin and, in case of insufficiency, vitamin D supplementation. Design: A prospective multicentre observational study where approximately 400 pregnant women with pre-existing diabetes are offered measurements of office blood pressure (BP) and home BP for three days three times during pregnancy as well as when the routinely measured office BP exceeds 135/85 mmHg. The prevalence of confirmed hypertension (office BP \>135/85 mmHg and home BP \>130/80 mmHg) and white coat hypertension (office BP \>135/85 mmHg but home BP ≤130/80 mmHg) will be determined. Women with confirmed hypertension are offered antihypertensive treatment mainly with methyldopa. In women with a) confirmed hypertension, b) white coat hypertension, and c) normal blood pressure before entering third trimester of pregnancy, the prevalence of preeclampsia and preterm delivery will be evaluated. Possible side effects of antihypertensive treatment including impaired fetal haemodynamics and lower infant birth weight will be recorded. The women will complete food diaries and questionnaires on lifestyle and mental health three times in pregnancy in order to evaluate the influence of these parameters on hypertension and preeclampsia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
513

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

4.7 years

First QC Date

August 31, 2016

Last Update Submit

May 25, 2021

Conditions

Pregnancy in Diabetics

Keywords

Blood pressureHypertensionWhite coat hypertensionPreeclampsiaAnti-hypertensiva

Outcome Measures

Primary Outcomes (7)

  • Confirmed hypertension

    Office blood pressure \>135/85 mmHg measured twice at least 4 hours apart and home blood pressure \>130/80 mmHg in pregnancy, or diagnosed hypertension with antihypertensive treatment from before pregnancy

    2 years

  • White coat hypertension

    Office blood pressure \>135/85 mmHg measured twice at least 4 hours apart, but home blood pressure ≤130/80 mmHg

    2 years

  • Preeclampsia

    4 years

  • Early preeclampsia

    Preeclampsia occurring before 34 weeks

    4 years

  • Preterm birth

    Birth before 37 completed weeks

    4 years

  • Early preterm delivery (international)

    Birth before 32 completed weeks

    4 years

  • Early preterm delivery (Danish)

    Birth before 34 completed weeks

    4 years

Secondary Outcomes (2)

  • Gestational hypertension

    4 years

  • Chronic hypertension

    4 years

Other Outcomes (26)

  • Infant birth weight SD-score

    4 years

  • Large for gestational age

    4 years

  • Small for gestational age

    4 years

  • +23 more other outcomes

Study Arms (2)

Pregnant women with pre-existing diabetes

Inclusion of 400 women is anticipated.

Drug: Antihypertensiva, mainly Metyldopa

Healthy pregnant women

Inclusion of 100 women is anticipated

Interventions

Antihypertensiva, mainly MetyldopaDRUG
Pregnant women with pre-existing diabetes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A cohorte of unselected consecutive pregnant women with pre-existing type 1 and type 2 diabetes will be included.

You may qualify if:

  • Women with diabetes diagnosed in pregnancy before 20 weeks (HbA1c ≥48 mmol/mol) may also be included as having type 2 diabetes.
  • Sufficient Danish language skills to read and understand the patient information sheet and to converse.
  • Women above 18 years of age, with a live singleton pregnancy, referred to a nuchal translucency scan at 11-14 weeks at The Department of Obstetrics, Rigshospitalet.
  • Sufficient Danish language skills to read and understand the patient information sheet and to converse.

You may not qualify if:

  • Women diagnosed with severe diseases that could possibly bias BP measurements or pregnancy outcome. This is judged by the principal investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Pregnant Women with Diabetes

Copenhagen, Kbh Ø, 2100, Denmark

Location

Related Publications (4)

  • Do NC, Vestgaard M, Asbjornsdottir B, Andersen LLT, Jensen DM, Ringholm L, Damm P, Mathiesen ER. Home Blood Pressure for the Prediction of Preeclampsia in Women With Preexisting Diabetes. J Clin Endocrinol Metab. 2022 Aug 18;107(9):e3670-e3678. doi: 10.1210/clinem/dgac392.

    PMID: 35766641DERIVED

  • Asbjornsdottir B, Vestgaard M, Do NC, Ringholm L, Andersen LLT, Jensen DM, Damm P, Mathiesen ER. Prevalence of anxiety and depression symptoms in pregnant women with type 2 diabetes and the impact on glycaemic control. Diabet Med. 2021 Mar;38(3):e14506. doi: 10.1111/dme.14506. Epub 2021 Jan 8.

    PMID: 33368557DERIVED

  • Do NC, Vestgaard M, Asbjornsdottir B, Nichum VL, Ringholm L, Andersen LLT, Jensen DM, Damm P, Mathiesen ER. Physical activity, sedentary behavior and development of preeclampsia in women with preexisting diabetes. Acta Diabetol. 2020 May;57(5):559-567. doi: 10.1007/s00592-019-01459-7. Epub 2019 Nov 28.

    PMID: 31781957DERIVED

  • Vestgaard M, Asbjornsdottir B, Ringholm L, Andersen LLT, Jensen DM, Damm P, Mathiesen ER. White coat hypertension in early pregnancy in women with pre-existing diabetes: prevalence and pregnancy outcomes. Diabetologia. 2019 Dec;62(12):2188-2199. doi: 10.1007/s00125-019-05002-9. Epub 2019 Oct 18.

    PMID: 31628489DERIVED

MeSH Terms

Conditions

Pregnancy in DiabeticsHypertensionWhite Coat HypertensionPre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesCardiovascular DiseasesHypertension, Pregnancy-Induced

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D student

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 7, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2020

Study Completion

February 1, 2021

Last Updated

May 26, 2021

Record last verified: 2021-05

Locations

DK(1)